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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 May 2016 |
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Main ID: |
NCT02558621 |
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Date of registration:
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23/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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New Robotic Assistance System for Spinal Fusion Surgery
AQrate |
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Scientific title:
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Clinical Trial on Performance and Acceptance of a New Robotic Assistance System During Spinal Fusion Surgery |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02558621 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Jean-Denis Patet, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinic Genolier, Switzerland |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients (age from 18 years to 85 years) scheduled for spinal fusion surgery,
- Primary spinal surgery (It is the first surgery on this patient's spine)
- Patient is capable of complying with study requirements, and
- Patient is willing to provide a signed informed consent.
Exclusion Criteria:
- Pregnancy and lactation
- Simultaneous participation in other clinical studies
- Infection or malignancy
- Previous spondylodesis
- Previous spinal surgical procedures
- Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral
palsy, neurofibroma)
- Spinal cord abnormalities with any neurologic symptoms or signs
- Paraplegia
- Any other significant disease or disorder which, in the opinion of the Investigator,
may either put the participants at risk because of participation in the study, or may
influence the result of the study.
- Patient cannot follow study protocol, for any reason
- Patient cannot or will not sign informed consent
- Patients in emergency situation, are not legally competent, cannot understand the
situation,
- Pediatric patients
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Spondylosis
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Degenerative Disc Disease
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Spondylolisthesis
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Spinal Stenosis
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Intervention(s)
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Device: AQrate Robotic Assistance System
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Primary Outcome(s)
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clinical acceptance of the performance of the AQrate Robotic Assistance System.
[Time Frame: Day of surgery]
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Secondary Outcome(s)
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Accuracy of spinal screws placed
[Time Frame: Within one month of surgery]
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Intraoperative exposure to radiation
[Time Frame: Day of surgery]
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Secondary ID(s)
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AQrate01/2015
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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